- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Powder for solution for infusion containing verteporfin.
Classic subfoveal choroidal neovascularisation in wet age-rel macular degen
Treatment of subfoveal choroidal neovascularisation secondary to myopia
Exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV).
Subfoveal choroidal neovascularisation secondary to pathological myopia.
Verteporfin therapy is a two-step process:
First, a 10 minute intravenous infusion of verteporfin at a dose of 6mg per square metre of body surface area, diluted in 30ml infusion solution.
Then, at 15 minutes after the start of the infusion, a light activation stage. For this, a diode laser generating non-thermal red light (wavelength 689 nanometre +/- 3 nanometre) is used via a slit lamp mounted fibre optic device and a suitable contact lens. At the recommended light intensity of 600 mW/cm squared, it takes 83 seconds to deliver the required light dose of 50J/square cm.
The greatest linear dimension of the choroidal neovascular (CNV) lesion is estimated using fluorescein angiography and fundus photography. Fundus cameras with a magnification within the range of 2.4 - 2.6X are recommended. All neovasculature, blood and/or blocked fluorescence should be covered by the treatment spot. To ensure treatment of poorly demarcated lesion borders, an additional margin of 500 micrometre should be added around the visible lesion. The nasal edge of the treatment spot must be at least 200 micrometre from the temporal edge of the optic disc. The maximum spot size used for the first treatment in the clinical studies was 6,400 micrometre. For treatment of lesions that are larger than the maximum treatment spot size, apply the light to the greatest possible area of active lesion.
Re-evaluate every 3 months. In the event of recurrent CNV leakage, therapy may be given up to 4 times per year.
There are no clinical data to support a concomitant treatment for the second eye. However, if the treatment of the second eye is deemed necessary, light should be applied to the second eye immediately after light application in the first eye but no later than 20 minutes from the start of the infusion.
Children under 18 years
Severe hepatic impairment
Precautions and Warnings
Moderate hepatic impairment
Advise visual disturbances may affect ability to drive or operate machinery
Avoid contact with mucous membranes
Avoid contact with skin or eyes
Do not use if solution is discoloured or particulates are apparent
If extravasation occurs follow local policy & seek expert help immediately
Treatment to be administered under the supervision of a specialist
Avoid exposure to pulse oximeters for 48 hours
Monitor for hypersensitivity reactions during infusion
Re-evaluate the patient every 3 months following treatment
Anaesthesia: may increase risk of severe adverse reactions
Do not re-treat patients with severe decrease of vision until full recovery
Discontinue if allergic reaction occurs
Breastfeeding: Do not breastfeed & discard milk for 48 hours after therapy
Advise patient to expose skin to ambient indoor light
Avoid exposure of unprotected skin/eyes to bright light for 48hr
UV sunscreens not effective in protecting against photosensitivity reaction
Pregnancy and Lactation
Use verteporfin with caution in pregnancy.
At the time of writing there is limited published information regarding the use of verteporfin during pregnancy. Therefore it should only be used if the benefits outweigh the potential risk to the foetus.
Studies in rats have shown teratogenic effects.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet (www.toxbase.org) or if this is unavailable at the backup site (www.toxbasebackup.org).
Use verteporfin with caution in breastfeeding.
Verteporfin and its metabolites are excreted in human breast milk. Breastfeeding should be withheld for 48 hours after verteporfin administration.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1.
Blood pressure changes
Discolouration (injection site)
Haemorrhage (injection site)
Inflammation (injection site)
Local pain (injection site)
Oedema (injection site)
Pain - generalised
Retinal or choroidal vessel nonperfusion
Retinal pigment epithelial tear
Variation in heart rate
Visual field defects
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: December 2017
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Martindale: The Complete Drug Reference. 39th Edition. London: Brayfield A (ed). Pharmaceutical Press; 2017.
Summary of Product Characteristics: Visudyne 15mg, powder for solution for infusion. Novartis Pharmaceuticals UK Ltd. Revised July 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 December 2017
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.